Method and device for treating aortic dissection

• US 20040176832A1
• Filed: 12/03/2003
• Published: 09/09/2004
• Est. Priority Date: 12/04/2002
• Status: Active Grant

• Current Assignee: Cook Medical Technologies, LLC (Cook Group Incorporated)
• Original Assignee: Cook Incorporated (Cook Group Incorporated), William A. Cook Australia Pty. Ltd (Cook Group Incorporated)
• Inventors: Hartley, David Ernest, Nixon, Ian, Mossop, Peter John
• Granted Patent: US 9,408,731 B2
• Time in Patent Office: Days
• US Class Current: 623/1.11
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/89 the wire-like elements comprising two or more adjacent rings flexibly connected by separate members
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2002/826 more than one stent being applied sequentially
• CPC Class Codes: A61F 2002/828 Means for connecting a plurality of stents allowing flexibility of the whole structure
• CPC Class Codes: A61F 2002/8483 Barbs
• CPC Class Codes: A61F 2002/8486 provided on at least one of the ends
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable

Abstract

A prosthesis adapted for inter-luminal placement by endovascular deployment for the treatment of vascular dissection, the prosthesis has a self expanding stents (38) connected together to define an elongate lumen wall engaging surface. At least one of the stents has a biocompatible graft material cover (36) to define a covered portion (25). The cover is adapted to close off a rupture (7) in the wall of the lumen (6) and the stents are adapted to provided pressure on the wall of the lumen adjacent to and extending away from the rupture.

Claims

1. A prosthesis adapted for inter-luminal placement by endovascular deployment, the prosthesis comprising a plurality of self expanding stents together defining an elongate substantially cylindrical lumen wall engaging surface and at least one of the stents having a biocompatible graft material cover defining a covered portion, whereby the cover is adapted to close off a rupture in the wall of the lumen and the stents are adapted to provided pressure on the wall of the lumen adjacent to and extending away from the rupture.

2. A prosthesis as in claim 1 wherein the cover encompasses at least two of the plurality of stents and the cover is stitched or otherwise fastened to the stents in the covered portion.

3. A prosthesis as in claim 1 wherein the covered portion of the prosthesis is at the proximal end of the plurality of stents.

4. A prosthesis as in claim 1 wherein uncovered stents extend away from the covered portion and are linked by flexible links.

5. A prosthesis as in claim 1 wherein uncovered stents extend away from the covered portion and are linked by a thread or fibre such as a suture threaded through the bends of the zig-zag stents.

6. A prosthesis as in claim 1 wherein the thread or fibre such as a suture is connected to each bend by a knot such as at least one of a half hitch, a thumb knot, two half hitches or a clove hitch.

7. A prosthesis as in claim 1 wherein a proximal end of the covered portion of the prosthesis includes barbs extending from a stent of the pluralities through the cover to engage with the wall of the lumen when deployed.

8. A prosthesis as in claim 1 wherein there are at least three covered stents of the plurality each of the zig-zag type and constructed from stainless steel or Nitinol and up to eight or ten uncovered stents of the plurality formed from stainless steel or Nitinol.

9. A prosthesis as in claim 1 wherein the uncovered portion is in the form of a self expanding spiral stent of zig-zag configuration.

10. A prosthesis for treatment of an aortic dissection comprising a substantially cylindrical body in an expanded state having at least one self expanding stent covered by a bio-compatible graft material and a self expanding stent assembly extending from a distal end thereof.

11. A prosthesis as in claim 10 further including included barbs extending from a proximal end of the graft material.

12. A prosthesis as in claim 10 wherein the self expanding stent assembly extending from a distal end of the biocompatible graft material is formed from a biocompatible and biodegradable mesh material.

14. A deployment device and prosthesis for treatment of an aortic dissection as in claim 12 wherein the elongate catheter includes means to supply an angiographic contrast medium at a distal end thereof through the catheter and the nose cone includes discharge ports for the angiographic contrast medium.

13. A deployment device and prosthesis for treatment of an aortic dissection, the prosthesis comprising a substantially cylindrical body in an expanded state having at least one self expanding stent covered by a bio-compatible graft material and a self expanding stent assembly extending from a distal end thereof, and the deployment device comprising an elongate catheter adapted to be deployed over a guide wire, a nose cone at the proximal end of the elongate catheter, a trigger wire arrangement adapted to retain a proximal end of the prosthesis in a retracted state, a sheath arrangement over the elongate catheter adapted to retain the prosthesis in a contracted state around the elongate catheter, means at the distal end of the elongate catheter to release the trigger wire arrangement and means to withdraw the sheath arrangement.

15. A method of treatment of aortic dissection disease comprising the steps of

a) loading a prosthesis onto a deployment device, the prosthesis comprising a plurality of self expanding stents together defining an elongate substantially cylindrical lumen wall engaging surface and at least one of the stents having a bio-compatible graft material cover, whereby the cover is adapted to close off a rupture in the wall of the lumen, the deployment device including means to retain a proximal end of the prosthesis in a retracted state and a trigger wire arrangement to release the proximal end of the prosthesis, a sheath to retain the entire the prosthesis in a retracted state and means to withdraw the sheath,

b) endovascularly deploying the deployment device with the prosthesis loaded thereon to the site of the aortic dissection,

c) checking by radiographic techniques that the covered stent or stents are at the site of the aortic dissection,

d) withdrawing the sheath to expose the covered stent or stents of the prosthesis,

e) releasing the proximal end of the prosthesis by means of releasing the trigger wire arrangement,

f) withdrawing the sheath to deploy the other stents of the prosthesis along the wall of the lumen such that they provide pressure against the wall of the lumen, and

g) withdrawing the deployment device.

16. A method of treatment of aortic dissection disease as in claim 15 wherein the covered stent or stents are at the proximal end of the prosthesis.